Status:
COMPLETED
Evaluation of the LipiFlow System With a New Activator
Lead Sponsor:
Johnson & Johnson Surgical Vision, Inc.
Conditions:
Meibomian Gland Dysfunction
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
Minimum 50 eyes and up to 100 eyes will be treated in this prospective, open-label clinical study. The investigator or designee will perform LipiFlow treatment with the Activators LFD-2100 on both eye...
Eligibility Criteria
Inclusion
- To be able to participate in this study, subjects must:
- Be at least 22 years old.
- Has been diagnosed as bilateral MGD prior to the study visit, or has evidence of MGD in both eyes. NOTE: MGD diagnosis can be based on prior medical records, investigator opinion or based on assessment of meibomian glands of the lower eyelid.
- Availability, willingness, ability and sufficient cognitive awareness to comply with study protocol, examination procedures and visit.
- Be willing to provide informed consent and authorization to disclose protected health information or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical procedures.
- Ability to understand and respond in English.
Exclusion
- Subject will not be able to be in the study, if the subject:
- Has a history of certain medical conditions that have been identified as contraindications and precautions of the LipiFlow System
- Has a history of prior eye surgery or trauma, active eye disease, or other eye abnormality in the study eye(s), which in the opinion of the investigator would confound the study results.
- Is pregnant, or is breast feeding.
- Concurrent participation or expected participation in an interventional (i.e., surgical or pharmaceutical interventional) clinical trial within 14 days prior to study screening.
Key Trial Info
Start Date :
October 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04500821
Start Date
October 2 2020
End Date
October 30 2020
Last Update
January 24 2022
Active Locations (3)
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1
Empire Eye and Laser Center
Bakersfield, California, United States, 93309
2
Wolstan & Goldberg Eye Associates
Torrance, California, United States, 90505
3
Texas Eye Research Center
Hurst, Texas, United States, 76054